Evidence map›Paper›PMID 25994543›Full record

Trial reportBMC cancer2015

Pegylated liposomal doxorubicin (Lipo-Dox®) combined with cyclophosphamide and 5-fluorouracil is effective and safe as salvage chemotherapy in taxane-treated metastatic breast cancer: an open-label, multi-center, non-comparative phase II study.

Kun-Ming Rau, Yung-Chang Lin, Yen-Yang Chen, Jen-Shi Chen, Kuan-Der Lee, Cheng-Hsu Wang, Hsien-Kun Chang

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 49 citations in OpenAlex.

  1. Pegylated liposomal doxorubicin (DuomeisuBreast cancer research and treatment · 2023
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Kun-Ming RauDivision of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. liu07822@ms57.hinet.net.
Yung-Chang LinCollege of Medicine, Chang Gung University, Tao-Yuan, Taiwan. yclinof@adm.cgmh.org.tw.
Yen-Yang ChenDivision of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. chenyy@cloud.cgmh.org.tw.
Jen-Shi ChenCollege of Medicine, Chang Gung University, Tao-Yuan, Taiwan. js1101@cgmh.org.tw.
Kuan-Der LeeDivision of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Chiayia, Chiayia, Taiwan. leecgmh@gmail.com.
Cheng-Hsu WangCollege of Medicine, Chang Gung University, Tao-Yuan, Taiwan. ph555chang@adm.cgmh.org.tw.
Hsien-Kun ChangDivision of Hematology-Oncology, Department of Internal Medicine, LinKo Chang Gung Memorial Hospital, 5, Fushing St., Gueishan Township, Taoyuan, 333, Taiwan. chk0329@seed.net.tw.
Chang Gung University · TWChang Gung Memorial Hospital · TWChiayi Chang Gung Memorial Hospital · TWKaohsiung Chang Gung Memorial Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnthracycline and taxane are classes of drugs that are frequently used in the adjuvant and palliative settings of metastatic breast cancer (MBC); however, treatment failure occurs in most cases. Limited data demonstrated favorable response in MBC after previous taxane-based treatment. The aim of this study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (Lipo-Dox®) used as part of a combination salvage therapy for patients with MBC whose tumors progressed during or after taxane-based treatment.

methodsPatients with MBC who failed to respond to previous taxane-based treatments were recruited. Treatment with pegylated liposomal doxorubicin (40 mg/m(2)), cyclophosphamide (500 mg/m(2)), and 5-fluorouracil (500 mg/m(2)) was administered every 3 weeks. Tumor response to treatment was determined by using the Response Evaluation Criteria in Solid Tumor criteria version 1.0, and left ventricular ejection fraction was measured before and after treatment using echocardiography. Each patient was followed for 30 days after the last dose of study medication or until resolution/stabilization of any drug-related adverse event.

resultsForty-five patients were recruited. As of December 2012, the median follow-up duration was 29.8 months, the overall response rate was 41.9 %, the median progression-free survival was 8.2 months, and the median overall survival was 36.6 months for all treated patients. Grade 3/4 neutropenia, leucopenia, and neutropenic fever were observed in 14 %, 9 %, and 1 % of the cycles, respectively. Other non-hematologic adverse effects were mild to moderate and were manageable. No decrease in left ventricular ejection function was noted.

conclusionThis regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects. This regimen could be considered as a treatment option for patients with MBC whose tumors progressed during or after taxane-based treatment.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsBridged-Ring CompoundsCyclophosphamideDoxorubicinFemaleFluorouracilFollow-Up StudiesHumansMiddle AgedNeoplasm MetastasisNeoplasm StagingPolyethylene GlycolsBiomarkers, TumorBridged-Ring CompoundsCyclophosphamideDoxorubicinFluorouracilliposomal doxorubicinPolyethylene GlycolstaxaneTaxoids

Identifiers

PMID25994543
PMCPMC4440506
OpenAlexW1488880565

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.